Blue Bell Creameries, Inc.

Summary of Root Cause Assessment

Broken Arrow, OK

February 12, 2016

Blue Bell Creameries Inc.

Summary of Root Cause Assessment

Broken Arrow, Oklahoma, Facility

After the discovery of Listeria monocytogenes (Lm) in certain ice cream products manufactured by
our company at our Broken Arrow facility, we began investigatory, sampling and remediation efforts
to control the situation, ultimately choosing to voluntarily shut down operations. With operations
voluntarily suspended, we focused on identifying potential sources of Listeria. We worked closely
with our outside experts to investigate potential avenues of Listeria, using the results of that
investigation to inform our corrective actions and updated procedures. We conducted this
investigation in parallel with ongoing remediation efforts with the goal of controlling and eliminating
potential sources of Listeria in all of our facilities.
We identified or learned about several lots of finished product produced at our Broken Arrow facility
that tested positive for the presence of Lm. We recalled affected product, ultimately recalling all
product produced at the Broken Arrow facility and suspending operations at this facility. Working
with our outside experts, we investigated the facility and equipment and collected extensive samples
from equipment and other surfaces in an effort to understand how Listeria may have become
present and how it could be prevented in the future. Equipment was disassembled and carefully
tested. The vast majority of these samples came back negative for Lm, but some tested
presumptive positive for Listeria species, Lm, or both. We focused critical attention on any
equipment associated with presumptive positive environmental findings or finished product, as well
as on equipment and facility design and employee practices.
During our investigation, we determined that cleaned equipment that contacts product after
pasteurization was being stored in a small room outside the sanitary production area. Equipment
was being stored in this room after it was sanitized. This room had a drain in the floor. We learned
that it was possible for particles capable of potentially carrying Listeria to be emitted from this
drain. The drains from the facility ultimately empty into the same system to which this drain was
connected, creating the potential for Listeria in the plant environment to be washed into the drains to
be re-released into the storage room. We believe that this mechanismparticles emitted from a
drainwas the most likely source of Listeria. We also identified potential sources associated with
two pieces of filling equipment, although these samples were identified after some construction had
been underway in the plant environment, making it unclear whether these samples reflected prior
operating conditions. Employee hygienic practices and equipment design may have been
contributing factors.
Based on this analysis, we identified and implemented specific corrective actions to address the
likely source of Listeria as well as facility-wide programs to enhance our overall ability to prevent
reintroduction of Listeria into the environment. As reported to FDA, we removed the equipment from
the storage room in question and no longer use that room for equipment storage. We have removed
the drain, filled and sealed the hole in the floor, and replaced the floor with a new (b) (4) floor. We
now use this space as an employee smock room. We identified and implemented corrective actions
. We also disassembled each piece of equipment, cleaning and
to enhance (b) (4)
sanitizing it before putting it back into operation, making modifications as necessary along the way.
We tested equipment after sanitizing it to verify that any Listeria had been eradicated.

Trade Secrets / Confidential Commercial Information. Exempt from disclosure under the Freedom of
Information Act, 5 U.S.C. 552(b)(4).

Blue Bell Creameries, Inc.

Summary of Root Cause Assessment
Broken Arrow, OK

February 12, 2016

We also took broad corrective actions, incorporating learnings from our investigation post-shutdown
and from our other facilities. We enhanced and refined our cleaning and sanitation programs and
retrained employees on the enhanced procedures. For example, we reviewed our procedures to
ensure we are using the appropriate water temperature and sanitizer concentration during cleaning
and sanitation activities. We also reviewed and enhanced our Good Manufacturing Practices
(GMPs), focusing on ensuring that employees follow good hygienic practices and handle equipment
and product appropriately. We shared these and other learnings across our facilities.
Further, we (b)

(4)

in our Broken Arrow facility. The (b) (4)

capable of destroying
Listeria, and we validated its effectiveness. We view our daily cleaning and sanitation programs and
employee GMPs as the first line of defense in preventing the reintroduction of Listeria, and we
periodically (b) (4) equipment to ensure that hard-to-clean areas are disinfected to reinforce our
routine sanitation efforts. Moreover, recognizing the potential for Listeria to become established in a
wide range of environments, prior to restarting production we (b) (4) our Broken Arrow facility and
treatment validated to destroy Listeria to key areas of the processing
administered a (b) (4)
and production areas of the facility before resuming production, providing us a clean slate from
which to begin operations. We conducted extensive environmental testing post-treatment to
verifying its effectiveness.

(b) (4)

We also reviewed and enhanced our environmental and product testing programs. We implemented
an enhanced environmental monitoring program to verify that our cleaning and sanitation procedures,
and other control measures are effective and to direct additional attention to any presumptive
positive findings to prevent reintroduction of Listeria. We developed a food contact surface and
finished product testing program, which we use as our test and hold program on all finished ice
cream product. Lots of ice cream are not released unless all relevant food contact surface and
finished product testing returns negative for Lm. Finally, working with our outside experts, we put
into place an enhanced ingredient oversight program so that key suppliers are appropriately qualified
and critical ingredients are subject to a testing regimen.
In sum, we believe that Listeria likely entered the facility through various potential sources and
eventually became present in the drain system. The Listeria then may have been released into the
air from the drain, thereby coming into contact with equipment and traffic into and out of the storage
room. We therefore directed our efforts at identifying a more appropriate storage location for
equipment, cleaning and sanitizing the production and processing areas of our facility, and
equipment, and enhancing our sanitation procedures and testing programs to protect against
reintroduction of Listeria. We believe that these enhanced programs are enabling us to effectively
control for Listeria in our Broken Arrow facility.

Trade Secrets / Confidential Commercial Information. Exempt from disclosure under the Freedom of
Information Act, 5 U.S.C. 552(b)(4).